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High Dose Oral Omeprazole in High Risk UGIB

High Dose Oral Omeprazole in High Risk UGIB

Recruiting
18 years and older
All
Phase N/A

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Overview

Peptic ulcer bleeding is the most common etiology in upper gastrointestinal bleeding all over the world. After endoscopic treatment, proton pump inhibitor (PPI) is recommended to prevent re-bleeding. Intravenous PPI is recommended as a standard treatment. In the past, there were many trials showing the efficacy of high-dose oral PPI after endoscopic hemostasis but most were industrial sponsor which assessing an expensive PPI. Moreover, the number of patients in those studies were insufficient to confirm a non-inferiority outcome in term of rebleeding by using oral PPI. This study will evaluate a high-dose, local-made PPI (omeprazole) in peptic ulcer treatment after successful endoscopic hemostasis compared to standard IV PPI continuous drip in term of rebleeding, as well as 24-hour gastric pH monitoring.

Eligibility

Inclusion Criteria:

  • Patients with peptic ulcer bleeding and endoscopic finding show ulcer with Forrest classification Ia (spurting haemorrhage), IIa (oozing haemorrhage), Ib (non-bleeding visible vessel)
  • Age \> 18 years old

Exclusion Criteria:

  • Deny to participate
  • Pregnancy or lactation
  • Low risk peptic ulcer bleeding including clean base ulcer, flat pigmented spot
  • Non-peptic ulcer bleeding eg. erosive gastritis/duodenitis, Mallory Weiss tear, esophageal/gastric/duodenal varices, vascular lesions (eg. Dieulafoy) , malignant ulcer
  • Bleeding tendency
  • Terminal stage of cancer
  • ESRD on hemodialysis
  • Decompensated liver cirrhosis

Study details
    GI Bleeding

NCT04394663

King Chulalongkorn Memorial Hospital

15 May 2026

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